In this free webinar, gain insights into the key considerations in evaluating whether a CDMO is a match for the program and company. Attendees will learn about the scopes of work (both development and manufacturing) that can and should be outsourced and the overall timeline that should be expected. The featured speakers will discuss the regulatory interactions that should occur during this process and when is the best timing. Attendees will learn about the value of hiring an external consulting team to guide this process.
TORONTO, Oct. 24, 2023 /PRNewswire-PRWeb/ -- Biotech companies frequently outsource their active pharmaceutical ingredients (API) and drug product manufacturing to CDMO. The reasons can vary — a biotech might make a strategic decision to outsource due to its limited internal know-how and capacity to manufacture API according to good manufacturing practice (GMP). For a biotech with limited clinical assets, this strategy is generally preferred to reduce costs and timelines.
How can a biotech manufacture GMP clinical trial material and successfully submit its investigational new drugs? To navigate a successful outcome for its clinical Phase I program, it must select a contract development and manufacturing organization whose capabilities are well matched to its needs.
Join this webinar to learn about some key challenges that companies will face in subcontracting biologics production to contract development and manufacturing organizations and how best to address these challenges.
Join experts from Alira Health, Sean Forestell, PhD, Director, CMC Operations; and Steven Chamow, PhD, Senior Vice President, CMC Development, for the live webinar on Wednesday, November 8, 2023, at 1pm PST (4pm EST).
For more information, or to register for this event, visit The Process of CDMO Selection for Antibody Development: Matching Capabilities to Need.
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